Phase 3
Completed N=180
Study of the Effectiveness of Cervical Ripening Balloon With and Without Oxytocin
Cervical Ripening · Induction of Labor · Multiparity
Source: ClinicalTrials.gov NCT03138252 ↗
Enrolled (actual)
180
Serious AEs
1.1%
Results posted
May 2022
Primary outcomePrimary: Time From Cervical Ripening to Delivery — 16.88; 13.13 hours
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Study Purpose: The purpose of this study is to determine the optimal method for induction of labor in multiparous women who present with an unfavorable cervix.
Hypothesis: Our hypothesis is that using oxytocin while the cervical ripening balloon is in place will result in more rapid labor courses, without increasing morbidity or increasing the need for operative delivery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Cervical Ripening to Delivery |
16.88; 13.13 | — |
Eligibility Criteria
Inclusion Criteria
- Age > 18 years
- Gestational age > 34 + 0/7 weeks
- Prior spontaneous vaginal delivery
- Clinical or U/S EFW of 1 prior C/S
Data sourced from ClinicalTrials.gov (NCT03138252). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.